FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867500976
Brand
Arthrex®
Company
ARTHREX, INC.
Model
76-10064
Catalog number
76-10064
Device description
Pin Adaptor QC AO 6mm
Published
2026-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXIGuide, drill, ligament
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXIGuide, Drill, LigamentGeneral, Plastic Surgery1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867500976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867500976008888675009768888675009760888867500976

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, reusableA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867050372Arthrex®AR-8934BNFAR-8934BNF2018-12-13
00888867290778Arthrex®AR-1938PSSAR-1938PSS2018-04-19
00888867348691Arthrex®AR-1934BCT-2AR-1934BCT-22022-07-11
00888867375116Arthrex®AR-8934BCSTAR-8934BCST2021-05-24
00888867375123Arthrex®AR-8934BCST-2AR-8934BCST-22021-05-24
00888867443624Arthrex®AR-2424PHSAR-2424PHS2024-01-25
00888867443631Arthrex®AR-2424PHS-1AR-2424PHS-12024-01-25
00888867384811Arthrex®AR-8934BCST-1AR-8934BCST-12021-05-24
00888867384828Arthrex®AR-8934BCST-2-1AR-8934BCST-2-12021-05-24
00888867285057Arthrex®AR-1934PF-24-1AR-1934PF-24-12020-12-15
00888867293830Arthrex®AR-1938PSS-1AR-1938PSS-12018-10-29
00888867335035Arthrex®AR-2923BCSAR-2923BCS2020-03-16
00888867088306Arthrex®AR-13110R-02AR-13110R-022017-02-15
00888867046641Arthrex®AR-8825BAR-8825B2017-02-15
00888867046672Arthrex®AR-8825PAR-8825P2017-02-15
00888867131491Arthrex®AR-8923BCAR-8923BC2017-02-15
00888867022874Arthrex®AR-1922BCAR-1922BC2017-02-15
00888867022959Arthrex®AR-1922PSAR-1922PS2017-02-15
00888867023017Arthrex®AR-1923BCAR-1923BC2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196320516MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-05
10080196320493MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-04
00190776423841MillenniumAvalign Technologies, Inc.MDM2026-08-26
00190776427641MillenniumAvalign Technologies, Inc.MDM2026-08-26
00810158217409PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
00850088713626PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
04054462913602evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913619evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913626evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913909evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913916evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913923evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913947evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913978evonosevonos GmbH & Co. KGMDM2026-08-25
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04054462913992evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914364evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914388evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914395evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914418evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914425evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914814evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914845evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914852evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914906evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914975evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914982evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914999evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915002evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915019evonosevonos GmbH & Co. KGMDM2026-08-25